Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients – a randomized controlled trial

Medical University of Vienna0 个研究点开始时间: 2017年7月12日最近更新: 2017年8月21日

试验速览

暂无简介。

•= 18 years of age
•Treatment with maintenance hemodialysis 3 times a week for = 3 months and =3
•sekundary hyperparathyroidism defined by
•o Parathyroid hormone levels obtained from the central laboratory of =300 pg/mL and no prior treatment with a calcimimetic drug, or
•o patients under treatment with cinacalcet who will be eligible following a washout phase of 4 weeks
•serum calcium levels obtained from the central laboratory of = 2.08 mmol/L
•Signs of left ventricular hypertrophy (increased myocardial thickness in the left ventricle, increased intraventricular septum thickness) +/- signs of cardiac fibrosis in cardiac imaging
•(Echocardiography)
•State of optimal fluid composition i.e. reaching the individual dry weight as measured
•with the help of a Body Composition Monitor. Pulmonary edema will be excluded with the help of lung ultrasound (lung comet tails).
•No substantial dose change of calcium supplements, phosphate binders, dialysate calcium 4 weeks before screening
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 31

•Unstable medical condition based on medical history, physical examination, and routine laboratory tests, or judged unstable in the investigator’s opinion
•Significantly impaired left ventricular systolic function or significant, hemodynamically effective heart valve defects
•History of any illness, which in the investigator’s opinion, might confound the results of the study or pose additional risk
•Anticipated parathyreoidectomy within 6 months after randomization
•Scheduled date for kidney transplant from a living donor
•Uncontrolled hyperphosphatemia
•Subject is currently enrolled in or has not yet completed at least 30 days since ending
•other investigational device or drug trial(s), or subject is receiving other
•investigational agent(s)
•Subject has known sensitivity or intolerance to any of the products to be
•administered for the purpose of this study
•Subject has any kind of disorder that compromises the ability of the subject to give
•written informed consent and/or to comply with the study procedures
•Subject is pregnant, or is of child-bearing potential and not using adequate contraceptive precautions
•Contraindications for MRI (implanted MR-Unsafe – objects that are significantly
•ferromagnetic and pose a clear and direct threat to persons and equipment within
•the magnet room)
•Overhydration as measured in BCM or visualized in lung ultrasound

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